Navane

"Feb. 22, 2011 -- The FDA has issued a safety announcement notifying health care professionals that it has updated the pregnancy section of drug labels for the entire class of antipsychotic medications.

For Patients

Navane (thiothixene hcl) is used to treat schizophrenia. It is an antipsychotic medication. This medication is available in generic form. Common side effects include dizziness or drowsiness, feeling restless or agitated, sleep problems (insomnia), breast swelling or discharge, changes in your menstrual periods, nausea, vomiting, diarrhea, constipation, changes in weight or appetite, dry mouth, increased thirst, or impotence, loss of interest in sex.

In milder conditions, an initial dose of 2 mg of Navane three times daily is recommended. If indicated, an increase to 15 mg/day total daily dose may be effective. In severe conditions, an initial dose of 5 mg twice daily is recommended. The usual optimal dose is 20 to 30 mg daily. Navane may interact with other medicines that make you sleepy (i.e., cold or allergy medicine, narcotics, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety), carbamazepine, blood pressure medications, atropine, benztropine, dimenhydrinate, methscopolamine, scopolamine, bronchodilators, glycopyrrolate, mepenzolate, bladder or urinary medications, or irritable bowel medications. Tell your doctor all medications you use. During pregnancy, Navane should be taken only if prescribed. It may be harmful to a fetus. It is unknown if this drug passes into breast milk or if it could harm a nursing baby. Consult your doctor before breast-feeding.

Our Navane (thiothixene hcl) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

SIDE EFFECTS

NOTE: Not all of the following adverse reactions have been reported
with Navane (thiothixene hcl) . However, since Navane (thiothixene hcl) has certain chemical and pharmacologic similarities
to the phenothiazines, all of the known side effects and toxicity associated
with phenothiazine therapy should be borne in mind when Navane (thiothixene hcl) is used.

Cardiovascular Effects: Tachycardia, hypotension, lightheadedness, and
syncope. In the event hypotension occurs, epinephrine should not be used as
a pressor agent since a paradoxical further lowering of blood pressure may result.
Nonspecific EKG changes have been observed in some patients receiving Navane (thiothixene hcl) .
These changes are usually reversible and frequently disappear on continued Navane (thiothixene hcl)
therapy. The incidence of these changes is lower than that observed with some
phenothiazines. The clinical significance of these changes is not known.

CNS Effects: Drowsiness, usually mild, may occur although it usually
subsides with continuation of Navane (thiothixene hcl) therapy. The incidence of sedation appears
similar to that of the piperazine group of phenothiazines but less than that
of certain aliphatic phenothiazines. Restlessness, agitation and insomnia have
been noted with Navane (thiothixene hcl) . Seizures and paradoxical exacerbation of psychotic symptoms
have occurred with Navane (thiothixene hcl) infrequently.

Hyperreflexia has been reported in infants delivered from mothers having received structurally related drugs.

In addition, phenothiazine derivatives have been associated with cerebral edema and cerebrospinal fluid abnormalities.

Extrapyramidal Symptoms

Extrapyramidal symptoms, such as pseudoparkinsonism, akathisia and dystonia
have been reported (see Dystonia, Class effect). Management of these
extra-pyramidal symptoms depends upon the type and severity. Rapid relief of
acute symptoms may require the use of an injectable antiparkinson agent. More
slowly emerging symptoms may be managed by reducing the dosage of Navane (thiothixene hcl) and/or
administering an oral antiparkinson agent.

Dystonia

Class effect: Symptoms of dystonia, prolonged abnormal contractions
of muscle groups, may occur in susceptible individuals during the first few
days of treatment. Dystonic symptoms include: spasm of the neck muscles, sometimes
progressing to tightness of the throat, swallowing difficulty, difficulty breathing,
and/or protrusion of the tongue. While these symptoms can occur at low doses,
they occur more frequently and with greater severity with high potency and at
higher doses of first generation antipsychotic drugs. An elevated risk of acute
dystonia is observed in males and younger age groups.

Persistent Tardive Dyskinesia: As with all antipsychotic agents, tardive
dyskinesia may appear in some patients on long-term therapy with thiothixene(1)
or may occur after drug therapy has been discontinued. The syndrome is characterized
by rhythmical involuntary movements of the tongue, face, mouth or jaw (e.g.,
protrusion of tongue, puffing of cheeks, puckering of mouth, chewing movements).
Sometimes these may be accompanied by involuntary movements of extremities.

Since early detection of tardive dyskinesia is important, patients should be
monitored on an ongoing basis. It has been reported that fine vermicular movement
of the tongue may be an early sign of the syndrome. If this or any other presentation
of the syndrome is observed, the clinician should consider possible discontinuation
of antipsychotic medication. (See WARNINGS section.)

Hepatic Effects: Elevations of serum transaminase and alkaline phosphatase,
usually transient, have been infrequently observed in some patients. No clinically
confirmed cases of jaundice attributable to Navane (thiothixene) have been reported.

Hematologic Effects: As is true with certain other psychotropic drugs,
leukopenia and leucocytosis, which are usually transient, can occur occasionally
with Navane (thiothixene hcl) . Other antipsychotic drugs have been associated with agranulocytosis,
eosinophilia, hemolytic anemia, thrombocytopenia and pancytopenia.

Allergic Reactions: Rash, pruritus, urticaria, photosensitivity and
rare cases of anaphylaxis have been reported with Navane (thiothixene hcl) . Undue exposure to
sunlight should be avoided. Although not experienced with Navane (thiothixene hcl) , exfoliative
dermatitis and contact dermatitis (in nursing personnel) have been reported
with certain phenothiazines.

Endocrine/Reproductive: Hyperprolactinemia(3); lactation,
menstrual irregularities, moderate breast enlargement and amenorrhea have occurred
in a small percentage of females receiving Navane (thiothixene hcl) . If persistent, this may necessitate
a reduction in dosage or the discontinuation of therapy. Phenothiazines have
been associated with false positive pregnancy tests, gynecomastia, hypoglycemia,
hyperglycemia and glycosuria.

NOTE: Sudden deaths have occasionally been reported in patients who
have received certain phenothiazine derivatives. In some cases the cause of
death was apparently cardiac arrest or asphyxia due to failure of the cough
reflex. In others, the cause could not be determined nor could it be established
that death was due to phenothiazine administration.